Concert Pharmaceuticals’ drug helps improve scalp hair growth in Alopecia Areata, data reveal CB News

Concert Pharmaceuticals, a company recently acquired by Sun Pharmaceutical Industries Limited, announced on Sunday the presentation of data from its Phase 3 clinical trial, THRIVE-AA2. The presentation highlights results from the THRIVE-AA2 study evaluating the oral investigational drug deruxolitinib in adult patients with moderate to severe alopecia areata, an autoimmune disorder that causes patchy or complete hair loss from the scalp. Data from THRIVE-AA2 are being presented by Brett King, MD, Ph.D., Department of Dermatology, Yale University School of Medicine and THRIVE-AA2 clinical investigator, during the 2023 American Academy of of Dermatology (AAD) Late Breaking News Session.

The primary efficacy endpoint of THRIVE-AA2 was the percentage of patients who achieved a Severity of Alopecia Tool (SALT) absolute score of 20 or less at week 24 of treatment compared to placebo As previously disclosed in the positive top-line results reported by Concert, significant improvements in scalp hair growth were achieved at 24 weeks for patients taking doses of 8 mg twice daily and 12 mg twice daily of deruxolitinib. The AAD filing includes new data from the THRIVE-AA2 study showing the ability of deruxolitinib to achieve near-complete or complete scalp hair growth, with 21% (8 mg twice daily) and a 35% (12 mg twice daily) of patients. , compared to 0% who received placebo, achieving a SALT score of 10 or less after 24 weeks.

The Phase 3 data presented at the AAD includes a comprehensive review of the THRIVE-AA2 results and further elaborates on the pivotal data reported in August 2022:

The primary efficacy endpoint for THRIVE-AA2 was the percentage of patients who achieved an absolute SALT score of 20 or less at week 24 of treatment.

A statistically significant proportion of patients treated with 8 mg twice daily or 12 mg twice daily of deruxolitinib experienced greater scalp growth compared to placebo. The proportion of patients who achieved a SALT score of 20 or less (ie, 20 percent or less scalp hair loss) was 38.3 percent in the 12 mg twice daily dose group times daily and 33.0 percent in the 8 mg twice daily dose group, compared with 0.8. percentage of patients in the placebo group, at the 24-week endpoint. The treatment difference for both dose groups of deruxolitinib versus placebo was statistically significant (p<0.0001).

Key secondary endpoints were the percentage of hair patient reported outcome (SPRO) response at week 24 and the percentage of patients achieving absolute SALT scores of 20 or less at each of the 20 weeks, 16, 12 and 8.47 % of patients in the 8 mg twice daily group and 52% of patients in the 12 mg twice daily group reported being “satisfied” or “very satisfied”, compared to 2 % of patients in the placebo group. The treatment difference for the two groups relative to placebo was statistically significant. SALT scores of 20 or less at weeks 20, 16, and 12 were statistically significant in both dose groups.

The safety profile observed with deruxolitinib in THRIVE-AA2 was consistent with previous studies. The most common side effects (≥5%) in any dose group were COVID-19 infection, nasopharyngitis, increased blood creatine kinase levels, acne, and headache. No pulmonary emboli or deep vein thrombosis were observed in the trial. Two patients treated with the dose of 8 mg twice daily and two patients treated with the dose of 12 mg twice daily developed herpes zoster (shingles). Five serious adverse events were reported in five patients, with one in the 8 mg twice daily dose group assessed as possibly related to treatment.

“These data are very encouraging and support the potential of deruxolitnib to regrow hair on the scalp, eyebrows and eyelashes in patients with alopecia areata, and in many cases with a rapid onset of effect,” he said. the Dr. King.

“We are pleased with the consistency of the Phase 3 results generated in the THRIVE-AA clinical program,” said James V. Cassella, PhD, Director of Concert Development. “Based on the strength of the data from THRIVE-AA2 together with the data from the THRIVE-AA1 trial and the continuation of our Breakthrough Therapy designation, deruxolitinib has the potential to be the best treatment option for alopecia areata areata. We look forward to submitting our new drug application for deruxolitinib to the Food and Drug Administration next quarter and offering this potential new treatment option to patients living with alopecia areata as soon as possible.”

The details of the oral presentation, titled “Results of THRIVE-AA2: A Phase 3, Double-Blind, Placebo-Controlled Clinical Trial of Deuruxolitinib (CTP-543), an Oral JAK Inhibitor, in Adult Patients with Moderate to Moderate Alopecia Areata severa”, are available in the Scientific Presentations section of the Concert website.